NF-κB Decoy Oligodeoxynucleotide-Coated Balloon Catheter for Arteriovenous Fistula in Hemodialysis.

New treatments to inhibit neointimal formation after percutaneous transluminal angioplasty (PTA) are needed for patients undergoing chronic hemodialysis (HD). We compared the efficacy and safety of AMG0102, a balloon catheter containing nuclear factor κB (NF-κB) decoy oligodeoxynucleotide (ODN) with the PTA balloon catheter (control group) for arteriovenous fistula (AVF) stenosis. In total, 175 patients (age ≥20 years, undergoing HD, with venous stenosis at the anastomotic region) were registered in this prospective open-label, randomized study. Patients were followed postoperatively for 36 weeks. The duration of primary patency on the targeted venous stenosis site (primary endpoint) was estimated by the Kaplan-Meier method. A lower restenosis risk was observed for the AMG0102 group, but it was not statistically significant (stratified log-rank test Further modifications to enhance NF-κB decoy ODN uptake and efficacy are necessary to show its clinical utility for AVF stenosis in chronic HD.